Data Foundry

Medical device recalls 2015

MEDPOR TITAN MAX Orbital Floor and Wall — Class II medical device recall Z-1093-2015

Terminated recall by Stryker Craniomaxillofacial Division, reported 2015-02-18, distributed nationwide. Article #81036 (MEDPOR Titan Max OFW - MTB - Right) reportedly contained article #81035 MEDPOR Titan Max OFW -

Recall numberZ-1093-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmStryker Craniomaxillofacial Division, Portage, MI, United States
Recall initiated2014-12-17
Classified2015-02-11
Reported by FDA2015-02-18
Terminated2015-11-06
DistributedNationwide (US)
Countries outside the USAR, AU, CA, CH, CL, CN, CO, ES, FR, KR, NL, SG, ZA
Quantity1,051
Lot numbersA1402020, A1405060
Model numbers81036

Product

MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER Implants are intended for the augmentation or restoration of bony contour in the craniofacial skeleton.

Reason for recall

Article #81036 (MEDPOR Titan Max OFW - MTB - Right) reportedly contained article #81035 MEDPOR Titan Max OFW - MTB - Left. The appropriate articles were actually included in the shipment. However, the products had an incorrect barrier location.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1093-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.